叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.179984399400996919941999390995490.21
210.129895398903989280.04
单位质量响应值RSD%判断
9788.509775.490.10数据可信
供试品溶液-23FA175批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118590-1859031.19732.204.8031.2032.204.80
220868-2086835.02035.02
319654-1965432.98332.98
418556-1855631.14031.14
518796-1879631.54331.54
618655-1865531.30731.31
10min128408-2840847.67450.464.7848.0250.824.77
232335-3233554.26454.65
330041-3004150.41450.78
428669-2866948.11248.46
530725-3072551.56251.91
630239-3023950.74751.09
15min134748-3474858.31460.563.9859.1961.483.98
238420-3842064.47665.47
335300-3530059.24060.17
434763-3476358.33959.22
536829-3682961.80662.73
636449-3644961.16862.08
20min137962-3796263.70765.742.6865.2367.342.65
238655-3865564.87066.58
339813-3981366.81468.40
438149-3814964.02165.55
540076-4007667.25568.87
640393-4039367.78769.38
30min141775-4177570.10672.172.7072.3474.492.67
242881-4288171.96274.39
343562-4356273.10575.43
442113-4211370.67372.91
542695-4269571.65074.01
645003-4500375.52377.87
45min144299-4429974.34276.992.7677.3580.122.73
245428-4542876.23779.47
346671-4667178.32381.46
444793-4479375.17178.20
546424-4642477.90881.06
647660-4766079.98283.17
60min144613-4461374.86979.914.5978.7183.894.50
250085-5008584.05288.13
347690-4769080.03384.04
445510-4551076.37480.23
548190-4819080.87284.89
649603-4960383.24387.32
90min146832-4683278.59382.184.5883.2687.054.48
251594-5159486.58491.59
348107-4810780.73285.63
446655-4665578.29683.00
548925-4892582.10587.02
651717-5171786.79191.79
极限146393-4639377.85682.234.4283.4088.014.33
251481-5148186.39592.37
348681-4868181.69687.49
447020-4702078.90884.49
548896-4889682.05787.89
651530-5153086.47792.44
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.179947599323992759921699151992880.13
210.129917099043991060.10
单位质量响应值RSD%判断
9762.839793.080.22数据可信
供试品溶液-23FA175批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120258-2025834.01133.612.9034.0133.612.90
220886-2088635.06535.07
319403-1940332.57532.58
419397-1939732.56532.57
519870-1987033.35933.36
620308-2030834.09534.09
10min130564-3056451.31350.961.9451.6951.331.94
230968-3096851.99252.38
329808-2980850.04450.41
429552-2955249.61449.98
530271-3027150.82151.19
630943-3094351.95052.33
15min136559-3655961.37861.041.8462.3361.981.83
237073-3707362.24163.21
335165-3516559.03859.96
436794-3679461.77362.69
536426-3642661.15562.09
636130-3613060.65861.61
20min139822-3982266.85666.671.9768.4968.281.95
240017-4001767.18468.84
338234-3823464.19065.76
440117-4011767.35268.95
539603-3960366.48968.10
640464-4046467.93469.56
30min143236-4323672.58872.751.8474.9675.111.80
243019-4301972.22474.63
342186-4218670.82573.11
444551-4455174.79677.14
543192-4319272.51474.87
643809-4380973.55075.94
45min145711-4571176.74377.132.6779.9280.302.59
245351-4535176.13979.35
344755-4475575.13878.21
448258-4825881.02084.20
545424-4542476.26279.42
646155-4615577.48980.69
60min146574-4657478.19279.013.1282.2283.033.02
246581-4658178.20482.26
345522-4552276.42680.34
449777-4977783.57087.65
546455-4645577.99282.00
647448-4744879.66083.72
90min148077-4807780.71681.362.1285.6286.262.09
248245-4824580.99885.92
347080-4708079.04283.80
450048-5004884.02589.03
548123-4812380.79385.67
649185-4918582.57687.52
极限147809-4780980.26681.612.9386.0687.412.84
248274-4827481.04686.87
346968-4696878.85484.49
451186-5118685.93591.88
548669-4866981.71087.48
648745-4874581.83787.70
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.172494322490742493232490272491822492080.07
210.122485002485022485010.01
单位质量响应值RSD%判断
24504.2324555.430.15数据可信
供试品溶液-AM222092批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139728-3972826.58725.962.1426.5925.962.14
238092-3809225.49225.49
339751-3975126.60226.60
437723-3772325.24525.25
538724-3872425.91525.92
638691-3869125.89325.89
10min160759-6075940.66242.932.8740.9643.222.84
264590-6459043.22543.51
365657-6565743.93944.23
465831-6583144.05644.34
564131-6413142.91843.21
663932-6393242.78543.07
15min188913-8891359.50359.160.8660.2559.920.85
287038-8703858.24859.01
388655-8865559.33060.11
489110-8911059.63560.40
588640-8864059.32060.09
688028-8802858.91159.67
20min1105864-10586470.84770.481.1272.2671.901.11
2103683-10368369.38770.80
3105795-10579570.80172.24
4106728-10672871.42572.86
5105722-10572270.75272.18
6104081-10408169.65471.07
30min1124285-12428583.17580.814.3585.3783.014.23
2120112-12011280.38282.56
3111036-11103674.30876.54
4125954-12595484.29286.52
5120486-12048680.63282.84
6122609-12260982.05384.24
45min1135110-13511090.41988.811.8193.5491.911.78
2129141-12914186.42589.50
3130350-13035087.23490.29
4134501-13450190.01293.17
5133471-13347189.32292.43
6133652-13365289.44392.55
60min1137630-13763092.10691.371.5596.2395.461.53
2133838-13383889.56893.60
3134145-13414589.77393.80
4137523-13752392.03496.20
5136821-13682191.56495.66
6139207-13920793.16197.26
90min1138868-13886892.93491.941.0898.0897.051.08
2135552-13555290.71595.75
3135664-13566490.79095.81
4138644-13864492.78497.97
5138250-13825092.52197.64
6137352-13735291.92097.05
极限1137024-13702491.70091.691.5497.8897.811.50
2134475-13447589.99496.03
3134652-13465290.11396.14
4137991-13799192.34798.56
5138066-13806692.39798.54
6139833-13983393.58099.73
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.172492882491302493652490172490512491700.07
210.122486042488312487180.07
单位质量响应值RSD%判断
24500.4924576.880.23数据可信
供试品溶液-AM222092批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146917-4691731.38731.461.7531.3931.461.75
247110-4711031.51631.52
348175-4817532.22832.23
446534-4653431.13131.13
545827-4582730.65830.66
647625-4762531.86031.86
10min175245-7524550.33849.692.2050.6950.042.20
273188-7318848.96249.31
375358-7535850.41350.77
474274-7427449.68850.03
571617-7161747.91148.25
676005-7600550.84651.20
15min194420-9442063.16662.492.5064.0763.392.49
291086-9108660.93561.83
395463-9546363.86364.78
493694-9369462.68063.58
590086-9008660.26661.14
695728-9572864.04164.96
20min1108612-10861272.66071.642.5674.2773.242.55
2105035-10503570.26771.84
3108983-10898372.90874.54
4107025-10702571.59873.19
5102798-10279868.77070.31
6110083-11008373.64475.27
30min1124089-12408983.01481.303.6185.4383.693.56
2114025-11402576.28178.63
3125705-12570584.09586.53
4122501-12250181.95184.34
5118740-11874079.43581.74
6124137-12413783.04685.49
45min1135134-13513490.40388.542.8093.7491.832.74
2131549-13154988.00491.20
3135465-13546590.62494.00
4125958-12595884.26487.56
5130924-13092487.58690.78
6135039-13503990.33993.71
60min1137867-13786792.23191.451.2196.5895.731.23
2134636-13463690.07094.25
3139096-13909693.05397.43
4137041-13704191.67995.92
5135355-13535590.55194.71
6136213-13621391.12595.50
90min1138887-13888792.91392.911.2098.2898.201.24
2136818-13681891.52996.71
3140851-14085194.22799.64
4139369-13936993.23698.49
5137046-13704691.68296.85
6140305-14030593.86299.25
极限1141378-14137894.58092.402.00100.9898.721.98
2135094-13509490.37696.57
3140888-14088894.252100.71
4138074-13807492.37098.66
5134887-13488790.23896.42
6138359-13835992.56098.99
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